Caries ActiveNCT07278180
Effects of Platelet and Leukocyte-rich Fibrin on Alveolar Ridge Maintenance Through Three-dimensional Analysis
An observational study of Caries Active and Tooth Decay, run by University of Guarulhos.
Trial summary
Understanding, through accurate and reliable volumetric analysis, how the biomaterial (LPRF) and the thickness of the vestibular bone plate influence changes in bone volume after extraction, is essential for making clinical decisions that impact implant-supported rehabilitation. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Active, Tooth Decay, Tooth Loss / Rehabilitation
- What is being tested?
- Alveolar socket preservation with graft and flap surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2016to 20 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with indication of tooth extraction
This prospective clinical study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and received approval from the Research Ethics Committee of Guarulhos University, São Paulo, Brazil (CEP-UnG #. 515.153). Thirty-nine patients (24 women and 15 men), aged between 22 and 80 years, who were in overall good health, non-diabetic, periodontally healthy, non-smokers, free of blood dyscrasias, not pregnant or lactating, and requiring extraction of non-contiguous, compromised teeth due to root fractures, caries, unsuccessful endodontic treatment, root resorption, or orthodontic reasons, were enrolled.
About this study
Official title: Assessment of the Effects of Platelet and Leukocyte-rich Fibrin on Vestibular Bone Plate Thickness on Alveolar Ridge Maintenance Through Three-dimensional Analysis
Understanding, through accurate and reliable volumetric analysis, how the biomaterial (LPRF) and the thickness of the vestibular bone plate influence changes in bone volume after extraction, is essential for making clinical decisions that impact implant-supported rehabilitation.
- Conditions
- Caries Active, Tooth Decay, Tooth Loss / Rehabilitation
- Being tested
- Alveolar socket preservation with graft and flap surgery
- Keywords
- tooth loss, decay, caries, biomaterials
- Medical subject headings
- Dental Caries, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar socket preservation with graft and flap surgeryProcedure or surgery
teeth to either the control group (coagulant-filled alveoli) or the test group (alveoli filled with platelet-rich fibrin and LPRF leukocytes)
| Study group | Role | What they receive |
|---|---|---|
| platelet rich firbrin | Not described Receives: Procedure: Alveolar socket preservation with graft and flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone volume after 16 weeks
Measured: 16 weeks
aveolar bone contraction
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start20 Jan 2016
- Primary completion20 Feb 2018
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries ActiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guarulhos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamil awad shibli, University of Guarulhos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278180
- Sponsor's protocol ID
- UnG 17917313.7.0000.5506
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Platelet and Leukocyte-rich Fibrin on Vestibular Bone Plate Thickness on Alveolar Ridge Maintenance Through Three-dimensional Analysis
- ClinicalTrials.gov ID
- NCT07278180
- Acronym / sponsor ID
- UnG 17917313.7.0000.5506
- Conditions
- Caries Active, Tooth Decay, Tooth Loss / Rehabilitation
- Keywords
- tooth loss, decay, caries, biomaterials
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GuarulhosUniversity, hospital or other
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Understanding, through accurate and reliable volumetric analysis, how the biomaterial (LPRF) and the thickness of the vestibular bone plate influence changes in bone volume after extraction, is essential for making clinical decisions that impact implant-supported rehabilitation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| platelet rich firbrin | – | Procedure: Alveolar socket preservation with graft and flap surgery |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with indication of tooth extraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar socket preservation with graft and flap surgeryteeth to either the control group (coagulant-filled alveoli) or the test group (alveoli filled with platelet-rich fibrin and LPRF leukocytes) | Procedure or surgery | platelet rich firbrin |
Primary outcome
bone volume after 16 weeks
Time frame: 16 weeks
aveolar bone contraction
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries Active and Tooth Decay, run by University of Guarulhos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone volume after 16 weeks (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.